If we didn’t have cold chain management, we would literally be losing our cool. Without it many of our daily necessities would simply spoil. Here’s a closer look at how this vital service helps us thru virtually every single day.

Imagine no refrigeration exists. Would the fish caught on Monday off the Newfoundland coast be just as fresh by the time it reached Winnipeg? Or what about the life-saving medicines that, in order to be fully effective have to be kept cool – would you trust them?

The cold chain and its proper operation has a direct impact on our daily lives, and managing it effectively is a game of high stakes.

What is Cold Chain Management?

Cold chain management covers the administration of all aspects of the cold chain itself. This includes processing, storage, transportation, monitoring and display of products that require a given level of refrigeration or climate control. Because of its direct impact on society’s overall health and well being, the cold chain employs higher levels of control and governance in place to assure product safety.

Along with climate controls, major components of cold chain management also include air quality (humidity, carbon dioxide and oxygen levels) and UV protection.

Typical products requiring cold chain management include food stuffs, beverages, chemicals, pharmaceuticals, medicines and medical products.

Due to the sensitive nature of products that require cold chain management, any type of disruption in the process, such as during processing, transportation, storage may result in serious losses from spoilage and financial liabilities. Therefor, maintaining an ideal temperature and product environment is critical for successful delivery to the end user.

With the aid of real-time tracking, temperature control, and the latest in thermal packaging technology, the cold chain is monitored, adjusted, monitored and tracked from point of origin through to delivery and final display.

Size of the Cold Chain Logistics Market

Thanks to an expanding market driven in part by the convenience of frozen foods, the size of the cold chain logistics market shows no signs of slowing down. According to predictions, it is in fact expected to nearly double is size in the next few years.

The global cold chain logistics market is projected to grow from $242.39 billion in 2021 to $647.47 billion by 2028, exhibiting a CAGR of 15.1% in forecast period…

Read More at: https://www.fortunebusinessinsights.com/cold-chain-logistics-market-106305

Reasons Why Cold Chain Management is So Important

With cold chain management, temperature sensitive products of all kinds avoid spoilage and maintain their integrity over longer periods. Here’s an overview of some of the most critical elements:

Product Safety

An unforeseen contamination due to spoilage is a great way to destroy a product, and company reputation. This is especially important with products within the medical industry. When making the wrong kinds of headlines, bad news is just bad for business.

Twenty four-seven monitoring of temperature, air quality, humidity levels, location, energy consumption, transportation, storage conditions all play their part in maintaining products within safe limits.

Product Integrity

Product integrity, safety, quality and viability depend on cold chain management. Modern cold chain management processes use the latest in thermal packaging, temperature tracking, monitoring, and storage which helps ensure consistent product expectations.

Reduced Waste and Spoilage

Waste, damage and loss are constant challenges faced by any supply chain. In highly competitive markets with tight margins, no company can afford to be wasteful of any resources related to their cold chain cargo. While some spoilage is expected and factored into operating costs, modernized tracking and monitoring systems are continually upgraded and used to keep spoilage and waste under control.

Improved Efficiency

Improving efficiencies and reducing costs keep costs under control. Finding ways to reduce them falls under the umbrella of the efficiency of all cold chain monitoring systems. For example, better cold chain management systems use integrated smart IoT-enabled tracking and monitoring. Systems such as these allow companies to streamline the transportation, delivery, and storage of products.

Compliance

Cold chain freight reaches virtually every corner of the globe, therefor strict governmental compliance and regulations must be upheld for every product that crosses international borders. Compliance with these regulations that govern the safe manufacture, storage, transport and delivery of temperature-sensitive products is a must.

For example, in the United States, the US FDA Food Safety Modernization Act (FMSA) rules centre around the prevention of food contamination.

Moreover, the CDC provides detailed guidelines for the maintenance and management of vaccines within cold chain. These include recommended storage temperature standards, temperature monitoring and vaccine storage requirements.

Additionally, IATA’s Temperature Control Regulations (TCR) is a publication used to ensure safe air shipping of pharmaceuticals. TCR requires special Time and Temperature Sensitive Labels to be used.

In the global sense, it is essential that companies from around the world stay up to date with the latest FDA, CDC, Canadian, EU, and WHO (World Health Organization) regulatory standards and guidelines.

Products That Depend on the Cold Chain

Chances are you’ve experienced what the lack of refrigeration does to your favourite ice cream. Without constant and consistent refrigeration it’s nothing but a runny mess. As much as the food industry might be top of mind, there are many facets that make up the global cold chain market:

Food: Again, one of the most common product categories that require a cold chain. Fresh and vegetables, meat, fish, poultry, seafood, dairy, frozen deserts, bakery goods and beverages are everyday examples of food items that need to be kept at specific temperatures to remain safe for consumption. If these food items aren’t stored or transported properly, they can spoil quickly due to contamination and bacterial growth.

Pharmaceuticals: Many pharmaceutical products such as medications, vaccines and insulin, must be kept at specific temperatures in order to remain safe and effective. Without protection throughout the cold chain ecosystem, these products can be exposed to hot or overly cold extremes which can cause a loss of potency or become unsafe for use.

Chemicals: Some specific chemicals require a cold chain for their storage and during transport. For example, many industrial chemicals must be stored at low temperature in order to remain in a stable state. If these chemicals become exposed to high temperatures, they can become volatile posing a danger to those within direct contact.

Medical: Perhaps a little closer to the bookends of life and death, products related to the medical industry greatly rely on the stability of well organized and maintained cold chain management. These products include organs and tissues meant for transplant, lab samples and blood products such as platelets and plasma.

If any of these items become exposed to extreme heat or cold, they can deteriorate quickly, lose their viability or become unsuitable for transplantation.

How Does the Cold Chain Process Work Logistically?

In cold chain logistics, a specific low-temperature range is maintained to ensure the quality and integrity of perishable goods. While some products require refrigeration, others must be frozen.

Cold chain logistics encompasses the activities of transportation, storage and handling of such items from the manufacturer or supplier to consumer.

Additionally, the data tracking process plays a critical part in cold chain logistics. Data logging in particular makes the management of the cold chain supply much easier. This technology also helps with quality assurance since any quality related issues can be addressed before they get out of hand.

All along the cold chain logistics process, maintaining product and packaging integrity throughout the storage and shipping stages present the highest potential for complications. This is when experience in cold chain management and familiarity with all its aspects becomes the greatest asset.

Is the Cold Chain Different from the Supply Chain?

In essence, the cold chain could be considered a specialized network within the overall supply chain. Another way to think of it as a temperature-controlled supply chain. Using the analogy of a chain, a successful cold chain requires the unbroken and stable links of refrigerated manufacture, production, packaging, transport, storage, and distribution.

Does your company deal with products that require cold chain management? If so, contact Brimich Logistics and Packaging today to take advantage of our Cold Storage operations!

“The most sweeping reform of U.S. food safety laws in more than 70 years.” implemented on Jan 4, 2011, was the result of a development program launched by the FDA under the Food Safety and Modernization Act (FSMA).

Recognizing the need for information regarding new regulatory requirements, the Food Processors of Canada (FPC) held an information session for its members on the impacts of the Preventive Control Rule. The well attended session of 50 participants represented a wide variety of Canadian food manufacturers.

Dr. David Acheson (former assistant commissioner for Food at the USFDA), and Cameron Prince (former vice-president of the Canadian Food Inspection Agency) of The Acheson Group, were invited by the FPC to provide background on FSMA.

The purpose was to highlight the main impacts of the Preventive Control Rule on Canadian food producers exporting to the U.S.

Some key points that came out of the session:

HACCP+

FSMA focuses on preventing, rather than being reactionary, to issues that can cause food-borne illness. The safety schedules apply to firms that manufacture, process, pack or hold food for humans.

These businesses are required to have written plans that identify hazards, specify the steps they’ve put in place to prevent or minimize or those hazards. In addition, they must clearly identify monitoring procedures and record monitoring results, plus specify actions to be taken to correct problems that arise.

When compared to similar HACCP and GFSI programs, there are differences in the new FSMA Preventive Controls Rule that will require companies to re-evaluate and adjust their programs.

With the Preventive Control approach, hazards related to the process, and to plant operation, are controlled under a prerequisite program that now requires the same level of diligence in:

• Documentation
• Monitoring
• Record keeping
• Corrective actions as a CCP under HACCP

The Preventive Control approach is portrayed as “HACCP+” in which Prerequisite Programs are identified as Preventive Controls requiring the same level of control as a CCP such as:

• Cleaning and Sanitation
• Allergen Control
• Recall

Products That Are “Ready-to-Eat”

Processors of Ready-to-Eat (RTE) products exporting to the U.S. may are required to implement an environmental pathogen monitoring program.

If the RTE product is open to the environment after processing and before packaging, and a kill step does not follow the packaging step, an environmental pathogen monitoring program is required.

Foreign Suppliers Verification

U.S. importers must also comply with the Foreign Suppliers Verification Rule, which means U.S. importers need to verify that Canadian Suppliers are in compliance with all U.S. Rules for FDA commodities. The verification could include an audit by the U.S. importer or a third party representing the U.S. importer.

Qualified Personnel

A qualified individual is required to develop, implement, and monitor the Preventive Controls Program by the Preventative Control Rule.

This individual is known as a Preventive Controls Qualified Individual (PCQI). Although experienced food safety managers can qualify for this position, it is strongly recommended that companies have a certified PCQI on staff.

In most cases this means a QA manager will be required to take a two-and-a-half day certified training program.

More than 131 million people use prescription drugs, which is 66% of all adults in North America according to the Georgetown Health Policy Institute. Many people depend on these drugs to manage severe or chronic conditions and maintain a certain quality of life.

The supply chain of prescription drugs and other pharmaceutical products must meet specific requirements. If a drug loses its quality or potency at some point between production and consumption, it offers no medicinal value.

Warehousing is a crucial component of the pharmaceutical supply chain management that contributes significantly to the wellbeing of millions of people.

General Information

In Canada, pharmaceuticals are regulated by the Health Products and Food Branch (HPFD) of Health Canada. In the United Sates, the Food and Drug Administration (FDA) regulates pharmaceuticals.

There are numerous regulatory standards that apply to pharmaceutical warehousing, products, and processes through the Good Manufacturing Practice (GMF) standards.

Included are several pharmaceutical warehousing requirements in the GMF standards:

• Warehouses must store drugs in a manner to prevent contamination, and that allows for thorough inspection and cleaning of the area.
• Each drug lot must have a unique and traceable code to allow for lot identification and lot status identification (approved, quarantined, rejected.)
• Each drug in the warehouse must have written procedures that describe the processes for distribution and recalls.
• The written procedures of each drug must describe appropriate storage conditions.

Appropriate storage requirements present unique challenges to pharmaceutical warehouses. Each drug has individual storage requirements in terms of temperature, lighting, and humidity. The warehouse must follow the drug manufacturer’s storage requirements to the letter.

Meeting storage requirements often involves setting and monitoring the environmental parameters of a storage section’s temperature- and climate control.

Temperature control involves controlling and monitoring the temperature of the facility.

Climate control refers to the regulation of a storage unit’s temperature and humidity.

What to Look for in a Warehouse Partner

A pharmaceutical warehousing provider should not only meet GMF standards, but the facility should also meet the following requirements:

• The warehouse should be sterile with enough space for storage, maintenance, and inspection.
• The facility should have sufficient ventilation and lighting.
• The facility should have a dedicated quarantine area for drugs that are no longer usable.
• The warehouse should have indoor and outdoor security systems in place to prevent unauthorized entry and theft.
• The warehouse should be able to store drugs without specific storage requirements at room temperature.
• The warehouse partner should be able to provide the client with written documentation of policies, distribution, inventory, and procedures.

Brimich Logistics for Pharmaceutical Warehousing

Brimich Logistics in Ontario provides a wide range of warehousing and value-added services. Our facilities are HACCP-compliant, and SQF certified. The benefits of Brimich Logistics include:

• Real-time data on inventory
• Efficient warehouse staff
• Facilities to store pharmaceutical drugs according to manufacturer instructions
• Industry-standard safeguarding against drug contamination

Brimich Logistics provides pharmaceutical clients in Ontario with responsive and reliable warehousing solutions. We are ready to assist you with your pharmaceutical warehousing solutions today. To learn more about our warehousing, logistics, value-added, and transportation services, contact us today.